Head Regulatory Affairs, Greater China

Major Responsibilities：

• Full responsibility of obtaining Marketing Authorizations for commercial products and if applicable Clinical Trial Authorizations as rapidly as possible in the country / countries of responsibility and to maintain these authorizations (variations and renewals).
• Full responsibility for the development and panning of clinical studies.
• Liaise between the CDRA departments in Italy, Germany and the UK and local offices (i.e. distributors, consultants, agents).
• Provide support to Commercial Operations with regulatory advice (prerequisites for sales should be guaranteed). 
• Create and maintain relationship with relevant authorities in China
• Create RA strategy and plan for required clinical trials, inc. budget and schedule
• Recruit and lead the CDRA team effectively to ensure that there is a fully competent/knowledgeable team, making sure there is support for other areas of the business in new products, and that resources are deployed appropriately.
• Manage Country interface with Country, Regional, and Global Development (Clinical and Regulatory), taking accountability for and optimizing all in-Country regulatory process and clinical trials, while ensuring their safety and compliance, and driving their ultimate success
• Input Country medical and clinical interests into Global and Regional strategy and planning, through active collaboration with key officers and participation in key forums
• Support dissemination of trial-generated medical information to educate key influencers, including scientific and regulatory leaders
• Monitors and influences license progress to expedite and optimise the outcome and from licence grant, on, ensures the continuing validity of the way the licence is used throughout the product life-cycle
• Provides regulatory advice to Corporate and relevant country on all aspects of development and licence maintenance work

Requirement：

• Advanced bioscience degree. MD strongly preferred
• Extensive experience in the pharmaceutical industry (7-10 years)
• International regulatory experience, time and quality conscious, assertive personality.
• Cutting-edge scientific and clinical understanding
• Experience in a Regional and/or HQ roles
• Excellent understanding of relevant (Country-specific) ethical and legal guidelines, and the ability to ensure compliance with these external guidelines as well as internal standard operating procedures
• Strong leadership skills, including demonstrated ability to effectively lead and coach scientific/ medical professionals, as well as business-oriented colleagues, at all skill and knowledge levels
• Excellent interpersonal, communication, negotiation, and presentation skills
• Significant experience of risk management
• Scientific/medical research experience with demonstrated record of scientific/medical publication desirable
• Fluent in Chinese and English are required.